Biotechnology for the Common Good

Human genes cannot be patented, says the U.S. Supreme Court.

Posted Jun 17, 2013

The Supreme Court's unanimous ruling that human genes may not be patented is "a victory for common sense." Those are the words of (among others) geneticist Mary-Claire King, who discovered one of the genes in question. Myriad Genetics, who patented the BRCA1 and BRCA2 genes and sold a genetic test based on analyzing them, lost the case. Pretty much everyone else won. This was the reaction of Eric Lander, one of the most distinguished of geneticists:

The Supreme Court got it exactly right. It’s a great decision for patients, it’s a great decision for science, and I think it’s a great decision for the biotechnology industry.

The court left several potentially significant issues explicitly undecided [pdf], so some uncertainty remains. But the fundamental principle is solid: No one can patent genes that are found in nature. The human genome is therefore part of what many national and international bodies have recognized as the “common heritage of humanity.”

It's also important to be clear that gene tests will still have limitations. The Myriad test only accounted for about 10% of all breast cancers; most women with breast cancer do not have those particular gene variants. But for those who do, like Angelina Jolie, the test is very valuable. It should now be significantly more accessible.

The decision was greeted with unbridled enthusiasm by the large coalition of plaintiffs and supporters. Among those is the Center for Genetics and Society (CGS), whose response is here. For background, the amicus brief that CGS and allies filed with the US District Court in 2009 is described and linked here; the 2012 follow-up brief to the Supreme Court is covered here and here. Similar briefs were filed by many others.

Press statements from the plaintiffs and their supporters came thick and fast, including these:

Myriad tried to spin the decision as a victory, by highlighting the Court's explicit refusal to rule on "method claims" or "the patentability of DNA in which the order of the naturally occurring nucleotides has been altered," and asserting that its cDNA claims were upheld. Possibly as a result, Myriad's shares initially rose, before falling back. However, Mark Lemley, a Stanford law professor, told Nature News that "cDNA may not end up being the subject of valid patents after all."

Some commentators called the ruling a "mixed decision" (Fierce Biotech, Bloomberg), or "scientifically inaccurate" (Forbes) and filled with "genetics errors" (PLoS blog) and "ignorance" (New Republic). In this, they seemed to be building on the brief concurrence by Justice Scalia, who was "unable to affirm those details [of molecular biology] on my own knowledge or even my own belief." However, in broad terms Scalia unequivocally agreed with the decision's key finding:

It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state ...

Legally, any scientific quibbles seem unlikely to become significant. Lori Andrews, of the IIT Chicago-Kent College of Law, who has been involved in these issues since the early days of the Human Genome Project, and helped to craft the lawsuit, has no doubt. From her excellent analysis of today's Supreme Court ruling:

If I spend a lot of money on a telescope to discover a new planet, I can't own the planet. A brief filed by the Department of Justice said that it was an error to let Myriad have the patents in the first place. So, paying Myriad nearly $4000 for each look at your breast cancer genes was like having to pay a car thief for the right to drive your own car.
Applause to the Supreme Court for getting this one right!

Bold in the original, and deservedly so. The struggle to ensure that modern genetic technologies are widely and appropriately used, and not abused, will continue for many years to come. But this Supreme Court decision is a vital step in the direction of making sure that biotechnology is used for the common good.

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